Xtalks Life Science Podcast artwork

Xtalks Life Science Podcast

174 episodes - English - Latest episode: 2 days ago -

This Life Science focused podcast brings together Xtalks editorial staff to share insights into the latest B2B industry news. Xtalks connects professionals in the life science, medical device, and food industries with useful content like webinars, job opening, articles and virtual meetings.

Life Sciences Science pharma pharmaceuticals biotech biotechnology medical device life science drug safety clinical research clinical trials drug development
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Episodes

Tackling Diabetic Kidney Disease: Featuring Robert Perkins, VP, US Medical Affairs (Renal), Bayer

March 27, 2024 09:00 - 18 minutes - 12.7 MB

In marking National Kidney Month, this episode features an interview with Robert Perkins, MD, Vice President, US Medical Affairs (Renal) at Bayer who spoke about kidney health and diabetes-inflicted chronic kidney disease. National Kidney Month is observed every March in the US to raise awareness about kidney health and promote preventive action. It aims to educate the public about the importance of kidneys to overall health and the risk factors for kidney disease, a major one being diabete...

People in Life Sciences Series: Day-in-the-Life of a Pharmacovigilance Professional – Interview with Ashish Jain, Senior Director of Clinical Safety and PV, Curis

March 20, 2024 04:00 - 34 minutes - 23.9 MB

In this featured episode of Xtalks People in Life Sciences, Ayesha spoke with Ashish Jain, Senior Director of Clinical Safety and Pharmacovigilance (PV) at Curis, a pioneering biotech company specializing in cutting-edge cancer therapies. Jain shared his journey into clinical safety and PV, highlighting key milestones along the way. Delving into his daily routine at Curis, he revealed his strategies for prioritizing tasks and staying informed of the latest developments in PV. Throughout th...

Building Cancer Awareness and Empowering Métis Youth: Featuring Jordyn Playne, President, Métis Nation of Ontario Youth Council

March 13, 2024 09:00 - 19 minutes - 13.4 MB

In this episode, Ayesha spoke with Jordyn Playne, President of the Métis Nation of Ontario Youth Council, a group of youth representatives from across Ontario who advocate on behalf of the concerns and interests of Métis youth at the provincial level. Jordyn is also a Clinical Consultant and Trainer at Waypoint Centre for Mental Health Care, as well as an advocate for cancer prevention. Jordyn has a Master’s degree in social work and licenses/certifications in cognitive behavioral therapy. ...

Transforming Eye Care: Innovating New Glaucoma and Dry Eye Disease Treatments

March 06, 2024 10:00 - 23 minutes - 16.6 MB

In this episode, Ayesha spoke with H. B. Pierre Simon Jr., MBA, Vice President, Global Head of Marketing, Sight Sciences, about the evolving field of eye care. Sight Sciences is focused on developing and commercializing innovative solutions for eye diseases like glaucoma and dry eye disease to transform care and improve patients’ lives. Among some of Sight Sciences devices and technologies include the OMNI® Surgical System, a minimally invasive glaucoma surgery (MIGS) device indicated to re...

Rare Disease Day 2024: Highlighting Patient Stories and Advancements in Rare Disease Research

February 28, 2024 10:00 - 33 minutes - 23.2 MB

In this episode, Ayesha talked about Rare Disease Day 2024, a global movement held on the last day of February each year that focuses on raising awareness about rare diseases including their impact on patients’ lives. This year, Rare Disease Day falls on February 29, the rarest day in a leap year, making it even more special. Ayesha spoke about how the Rare Disease Day campaign helps increase awareness about rare diseases, promotes research and development, supports advocacy for policies su...

Biologics Development in Immunology and Inflammation — Featuring Amir Reichman, CEO of Scinai Immunotherapeutics

February 21, 2024 10:00 - 25 minutes - 17.4 MB

This episode features an interview with Amir Reichman, CEO of Scinai Immunotherapeutics, a biopharma company focused on developing, manufacturing and commercializing cutting-edge biological treatments within the inflammation and immunology (I&I) sector, with a primary focus on addressing autoimmune and infectious diseases. Scinai Immunotherapeutics is working on developing nanosized antibodies from alpacas, known as VHH-antibodies or NanoAbs, which show promise as improved biological therap...

Novel Approaches in Cancer Immunotherapy — Featuring OncoC4 founder, CEO and CSO Dr. Yang Liu and CFO Abid Ansari

February 14, 2024 10:00 - 24 minutes - 17 MB

This episode features an interview with Yang Liu, PhD, founder, chairman, CEO and chief scientific officer; and Abid Ansari, MBA, chief financial officer at OncoC4, a clinical-stage biopharmaceutical company focused on developing novel treatments for cancer. This includes first-in-class immunotherapy products such as novel antibodies and CAR T-cell treatments targeting CTLA-4. OncoC4 is a spinout of OncoImmune, which was acquired by Merck in December 2020. OncoImmune was founded in 2000 bas...

New Targeted Treatments for Breast Cancer — Conversation with Dr. Carlos Doti, VP, US Medical Affairs Oncology, AstraZeneca

February 07, 2024 14:00 - 22 minutes - 15.5 MB

This episode features an interview with Carlos Doti, MD, Vice President, US Medical Affairs Oncology, AstraZeneca, about new breast cancer treatments. Dr. Doti is a hematologist by training and is passionate about developing treatments that have a real impact for people living with cancer across every aspect of their disease. Dr. Doti has worked in industry for the last 14 years, including seven years at AstraZeneca in various roles, and in small markets like Argentina as well as larger glo...

Untitled Episode

February 07, 2024 05:00 - 22 minutes - 15.8 MB

Exploring the Endocannabinoid System for Drug Development, Featuring Punit Dhillon, Chairman & CEO of Skye Bioscience

January 31, 2024 10:00 - 24 minutes - 16.9 MB

This episode features an interview with Punit Dhillon, Chairman & CEO of Skye Bioscience, a pharmaceutical company developing proprietary molecules to treat diseases involving inflammatory, fibrotic and metabolic conditions. Skye Bioscience is at the forefront of exploring the endocannabinoid system for drug development. Punit brings two decades of experience as a leader and investor within the life sciences sector. During the interview, he shared his journey leading up to his role at Skye ...

Life Science Trends for 2024

January 24, 2024 05:00 - 43 minutes - 29.6 MB

In this episode, Ayesha talked about some of the trends in the life sciences to watch out for in 2024. From the increasing integration of artificial intelligence (AI) and machine learning (ML) tools in drug development to medically accurate health wearables, hear about the trends and innovations that will be shaping the life sciences this year. Ayesha spoke to industry experts and innovators in the pharmaceutical, biotechnology and medical device spaces to learn more about these trends and ...

Revolutionizing Orthopedic Joint Replacement — Interview with Ben Sexson, Co-Founder, CEO, Monogram Orthopedics

January 17, 2024 10:00 - 37 minutes - 25.7 MB

This episode features an interview with Ben Sexson, CFA, Co-Founder, CEO, Monogram Orthopedics at Monogram Orthopedics, a company dedicated to revolutionizing orthopedic joint replacement through surgical robotics. Monogram is focused on developing patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging. Ben is an engineer by training and prior to joining Monogram, he served as the Director of Business Development at Pro-Dex, a...

Cognitive and Neuropsychiatric Disorders Drug Development, Featuring Dr. Adam Kaplin, Cofounder, President, CSO, MIRA Pharmaceuticals

January 10, 2024 10:00 - 56 minutes - 39.1 MB

This episode features an interview with Adam Kaplin, MD, PhD, Cofounder, President and Chief Scientific Officer at MIRA Pharmaceuticals, a preclinical-stage pharmaceutical company focused on the development and commercialization of new molecular synthetic cannabinoid analogs for the treatment of anxiety and cognitive decline typically associated with early-stage dementia. Dr. Kaplin is a neuropsychiatrist whose research focuses on the investigation of the biological basis of immune-mediate...

Pneumococcal Vaccination for Adults: Conversation with Vaccine Scientists Dr. Heather Platt and Dr. Ulrike Buchwald from Merck

December 13, 2023 10:00 - 43 minutes - 29.9 MB

This episode features an interview with vaccine scientists and executives from Vaccines Global Clinical Development at Merck, Dr. Heather Platt, MD, Distinguished Scientist and Pneumococcal Vaccine Lead; and Dr. Ulrike Buchwald, MD, Scientific Associate Vice President, Global Clinical Research and Pneumococcal Vaccine Section Head. Over the past ten years, Dr. Platt has worked across both infectious disease and vaccines products in both early- and late-stage clinical research. In her curren...

A Focus on Men's Health — Conversation with Fady Boctor, Petros Pharma President and CCO

December 06, 2023 10:00 - 22 minutes - 15.7 MB

This episode features an interview with Fady Boctor, MBA, President and Chief Commercial Officer at Petros Pharmaceuticals, a Men’s Health pharmaceutical company that aims to develop complementary therapeutics designed for a man’s journey. The company focuses on therapeutics that promote medication adherence, tolerability and preservation of male organic function. Fady has over 20 years of experience in the pharmaceutical industry, and has worked for companies such as Novartis, Forest Pharm...

“Off-the-Shelf” Cellular Therapy: Interview with Longeveron CEO Wa'el Hashad

November 29, 2023 10:00 - 34 minutes - 23.5 MB

This episode features an interview with Wa'el Hashad, CEO of Longeveron. Hashad discussed Longeveron’s mission and the therapeutic areas the company is investigating. He discussed the mechanism of action of the company’s lead program, Lomecel-B. Lomecel-B is an “allogeneic” (donor-derived) cell therapy product. Lomecel-B is a cellular therapy currently under clinical investigation as a potential treatment for various aging-related chronic diseases and life-threatening conditions. These stu...

Attorney Tope Leyimu Discusses Proposed FDA ban on Hair Relaxer Products Containing Harmful Chemicals

November 22, 2023 05:00 - 20 minutes - 14.4 MB

This episode features an interview with Attorney Temitope (Tope) Leyimu, a toxic exposure attorney at Motley Rice  who is leading a lawsuit over hair relaxing products that contain harmful chemicals.   Hair relaxing products are used for straightening/smoothening hair and many contain harmful formaldehyde, formaldehyde-releasing and other toxic chemicals. The FDA recently issued a recommendation for the recall of chemical hair relaxers containing harmful chemicals. While the agency has initi...

Dr. Lahar Mehta Speaks About New Trial to Evaluate ALS Drug for Progressive Supranuclear Palsy

November 15, 2023 10:00 - 25 minutes - 17.8 MB

This episode features an interview with Dr. Lahar Mehta, Head of Global Clinical Development at Amylyx Pharmaceuticals, who spoke to Xtalks about Amylyx’s clinical trial design of ORION, a Phase III Global Study of AMX0035 (Relyvrio) in Progressive Supranuclear Palsy (PSP). The company presented details about the trial at the Neuro2023 PSP and CBD International Research Symposium that took place in London last month in October. The ORION study will evaluate the safety, efficacy, and tolera...

FDA Considers Self Administered Nasal Flu Vaccine + Wayne Gretzky Features in GSK RSV Vaccine Ad

November 08, 2023 10:00 - 31 minutes - 22 MB

In this episode, Ayesha talked about the FDA’s acceptance of AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. While FluMist has been in the market since 2003, AstraZeneca is now seeking FDA authorization for a self-administered option of the vaccine. By offering a more accessible and flexible self-administered option, the company and experts in the field hope it will help increase uptake of the...

Innovations and Clinical Trial Diversity in Medical Aesthetics: Insights from Dr. Stephanie Manson Brown, VP & Head of Clinical Development at Allergan Aesthetics

November 01, 2023 09:00 - 32 minutes - 22.6 MB

Visit clinicaledge.xtalks.com/issue1 to dive into the first issue of Xtalks Clinical Edge magazine and be a part of the conversation shaping the next era of clinical trials. Xtalks Clinical Edge — "where innovation meets expertise!" This episode features an interview with Dr. Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement...

Dr. Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Speaks About Clinical Trial Diversity in the Medical Aesthetics Space

November 01, 2023 09:00 - 32 minutes - 22.6 MB

Visit clinicaledge.xtalks.com/issue1 to dive into the first issue of Xtalks Clinical Edge magazine and be a part of the conversation shaping the next era of clinical trials. Xtalks Clinical Edge — "where innovation meets expertise!" This episode features an interview with Dr. Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement...

Lead Investigator Dr. Genevieve Neal-Perry Discusses New Trial Data for Astellas’ Menopause Drug Fezolinetant (Veozah)

October 25, 2023 13:00 - 22 minutes - 15.4 MB

This episode features an interview with Dr. Genevieve Neal-Perry, MD, PhD, professor and chair at the UNC School of Medicine Department of Obstetrics and Gynecology, and lead investigator on a study investigating Astellas Pharma’s fezolinetant (Veozah), which received FDA approval in May this year for the treatment of moderate to severe vasomotor symptoms due to menopause. It’s the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat vasomotor symptoms, which include ...

Johnson & Johnson Faces Lawsuit Over Patient Data Breach + Sleepiz’s Sleep Monitoring Device Gets FDA Clearance

October 18, 2023 09:00 - 26 minutes - 18.2 MB

In this episode, Ayesha talked about a lawsuit that Johnson & Johnson and IBM are facing over a data breach that occurred at Janssen’s CarePath, Johnson & Johnson’s patient assistance program, the portal for which is run by IBM. The lawsuit was filed with the federal court in the Southern District of New York by a Florida resident who claims the companies failed to adequately protect patients’ personal identity and health information as per the Health Insurance Portability and Accountability...

Advancing CAR T Cell Therapies in Immuno-Oncology – Featuring Dr. Paul Rennert, CEO, CSO, Aleta Biotherapeutics

October 11, 2023 09:00 - 47 minutes - 32.8 MB

This episode features an interview with Dr. Paul Rennert, co-founder, CEO and CSO of Aleta Biotherapeutics, an immuno-oncology company focused on multi-antigen targeting solutions designed to enhance the action of CAR T cell therapies in B cell lymphoma, B cell leukemia and multiple myeloma, as well as non-B cell cancers such as acute myeloid leukemia (AML) and solid tumors such as breast cancer, gastric cancer and pediatric brain tumors. Dr. Rennert spoke to Xtalks about CAR T cell engager...

New HPV Vaccine Data Shows Long-Term Impact – Featuring Dr. Elmar Joura from the Medical University of Vienna

October 04, 2023 14:00 - 20 minutes - 14.1 MB

This episode features an interview with Dr. Elmar Joura, Associate Professor of Gynecology in the Department of Obstetrics and Gynecology at the Medical University of Vienna, who spoke to Xtalks about exciting new long-term Gardasil vaccine data from a study he led as principal investigator that showed the long-term impact of HPV vaccination. Merck recently announced new, 10-year long-term follow-up data published in the journal, Pediatrics, for girls and boys who received a three-dose regi...

Interview with Dr. Kristin Yarema, President of Cell Therapy at Poseida Therapeutics

September 27, 2023 09:00 - 33 minutes - 23.4 MB

In this episode, Vera interviews Dr. Kristin Yarema, President of Cell Therapy at Poseida Therapeutics, about Poseida’s cell therapy approach and technologies. In April 2023, Dr. Yarema became the President of Cell Therapy at Poseida. She brings a wealth of knowledge from the biopharmaceutical realm, with expertise in oncology and allogeneic T-cell immunotherapy. Poseida is a clinical-stage biopharmaceutical firm that utilizes its unique non-viral gene engineering methods to develop innova...

Advancements in Blood-Based Biomarker Tests for NASH — Interview with Dr. Tania Kamphaus and Tony Villiotti

September 20, 2023 09:00 - 41 minutes - 28.7 MB

This episode features an interview with Dr. Tania Kamphaus and Tony Villiotti about new research on the utility and promise of blood-based biomarker tests for the diagnosis of liver diseases like non-alcoholic steatohepatitis (NASH). The research is particularly timely because the American Diabetes Association (ADA) recently called for liver disease screening for all adults with type 2 diabetes. The research, published in Nature Medicine, presents results from a study that evaluated blood-...

Advancements in Blood-Based Biomarker Tests for NASH — Interview with Dr. Tania Kamphaus and Tony Villioti

September 20, 2023 09:00 - 41 minutes - 28.7 MB

This episode features an interview with Dr. Tania Kamphaus and Tony Villiotti about new research on the utility and promise of blood-based biomarker tests for the diagnosis of liver diseases like non-alcoholic steatohepatitis (NASH). The research is particularly timely because the American Diabetes Association (ADA) recently called for liver disease screening for all adults with type 2 diabetes. The research, published in Nature Medicine, presents results from a study that evaluated blood-...

Insights into New Alzheimer's Treatments: Treating Agitation and First THC-Based Therapeutic in Trials — Interview with IGC's Ram Mukunda and Claudia Grimaldi

September 13, 2023 09:00 - 34 minutes - 24 MB

This episode features an interview with Ram Mukunda and Claudia Grimaldi from IGC Pharma, a clinical-stage pharmaceutical company focused on improving the health and well-being of patients affected by Alzheimer’s disease and bringing therapies for it to market. The company is currently conducting a Phase II study with IGC-AD1, an investigational low-dose tetrahydrocannabinol-(THC) based formulation that reduces neuropsychiatric symptoms such as agitation in dementia due to Alzheimer’s. The...

Discussing Next Generation Chemotherapy Drugs with Processa Pharma’s Dr. David Young

September 06, 2023 09:00 - 30 minutes - 21.3 MB

This episode features an interview with Dr. David Young, founder and President R&D at Processa Pharmaceuticals, a clinical-stage pharmaceutical company developing personalized approaches to cancer treatments with a focus on next generation chemotherapy drugs with improved safety and efficacy. Processa recently released an update on its clinical cancer program, which Dr. Young discussed with Xtalks in this podcast episode. Dr. Young is Processa’s initial founder, President of R&D and former ...

More US States Take on Eli Lilly in Court Over Proposed Insulin Pricing Settlement + Regeneron's High Dose Eylea Wins FDA Approval

August 30, 2023 09:00 - 25 minutes - 17.4 MB

In this episode, Ayesha talked about how three more US states have filed a lawsuit against Eli Lilly over its proposed $13.5 million insulin pricing settlement. The states join six others who have been fighting Eli Lilly in court since 2017, claiming that the company hiked prices of its insulin product Humalog. The states say the $13.5 million settlement offer from Eli Lilly doesn’t come close to the $1 billion worth of claims the company is facing. Hear more about the insulin pricing contro...

Interview with BriaCell's CEO Dr. William Williams

August 23, 2023 09:00 - 25 minutes - 17.6 MB

This episode features an interview with Dr. William Williams, CEO of Briacell Therapeutics, a biotech company based in Philadelphia that is dedicated to developing novel immunotherapies to fight cancer and improve patient lives. Dr. Williams is a seasoned biopharmaceutical executive with over 35 years of industry and academic expertise, including significant clinical management in multinational pharmaceutical companies like Incyte Corporation and GlaxoSmithKline. Dr. Williams has facilitate...

First Oral Tablet for Postpartum Depression + Court Rejects JJ's Latest Bankruptcy Attempt

August 16, 2023 09:00 - 30 minutes - 20.8 MB

In this episode, Ayesha talked about the FDA approval of Zurzuvae (zuranolone) the first oral tablet for the treatment of postpartum depression (PPD). While the approval is a major win in PPD, as current treatments involve administration by infusion or use of general antidepressants, Zurzuvae developers Biogen and Sage Biotech were banking on getting approval for it in major depressive disorder (MDD). However, the FDA rejected it in MDD and only handed the approval in PPD. Hear more about th...

FDA Clearances for World's Smallest Insulin Pump + New Cardiac Biomarker Test

August 09, 2023 09:00 - 23 minutes - 15.9 MB

In this episode, Ayesha talked about the FDA clearance of the world’s smallest insulin pump from Tandem Diabetes Care. The insulin pump, called the Tandem Mobi, features an automated insulin delivery system with options for manual delivery as well. The device is small enough to fit into the coin pocket of a pair of jeans and offers several wearable options. It can be operated through an app and also features technology compatible with continuous glucose monitoring systems.  Ayesha and the t...

In Conversation with Principal Investigator and SME Dr. Lawrence Eichenfield About the FDA Approval of a Drug-Device Combo for Common Skin Infection

August 02, 2023 09:00 - 23 minutes - 16 MB

This episode features an interview with Dr. Lawrence Eichenfield, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego, and professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine.  Dr. Eichenfield serves on Verrica Pharmaceuticals’ Board of Directors and spoke to Xtalks about the company’s recent approval of YCANTH (cantharidin) topical solution as the first FDA approved treatment for pediatri...

Point-of-Care Testing for Infectious Diseases: Senzo CEO Jeremy Stackawitz Speaks About Company’s New Lateral Flow Technology

July 26, 2023 09:00 - 55 minutes - 38.3 MB

This episode features an interview with Jeremy Stackawitz, CEO at Senzo, a London-based MedTech company that has developed a new lateral flow technology for infectious diseases with the same accuracy as central labs testing. Jeremy, who was formerly at companies like Quotient and Johnson & Johnson, discussed how the development of this technology can unlock new models of care such as personalized, preventative and remote healthcare. Senzo’s products and systems bring testing to the patien...

Biosimilars and the Problem with PBMs: Interview with Juliana M. Reed, Executive Director of the Biosimilars Forum

July 19, 2023 09:00 - 35 minutes - 24.5 MB

Uptake of biosimilars is lagging in the US, but why? In this episode, Sarah interviews Juliana M. Reed, Executive Director of the Biosimilars Forum, to find out the real barriers to widespread access to biosimilars, and how these problems could be addressed. Julie discusses the role of pharmacy benefit managers (PBMs) and the incentives that keep them from listing most biosimilars on their formularies. She applauds the recent launch of multiple new biosimilars for the blockbuster biologic H...

Opioid Use Disorder and Brixadi Approval: Interview with Dr. Joshua Cohen, Chief Medical Officer at Braeburn

July 12, 2023 09:00 - 15 minutes - 10.5 MB

In this episode, Sarah interviews Dr. Joshua Cohen, Chief Medical Officer at Braeburn, who talks about the stigma associated with opioid use disorder (OUD), and how our treatment of this condition is changing. Dr. Cohen talks about the recent FDA approval of Brixadi, the first long-acting buprenorphine treatment for opioid use disorder that has both weekly and monthly dosing options, and explains the technology behind its extended-release formula. Read the full article here: Brixadi Is a ...

Developing More Affordable Cellular Immunotherapies: Interview with CytoMed Therapeutics

July 05, 2023 09:00 - 28 minutes - 19.4 MB

In this episode, Vera interviews two experts from CytoMed Therapeutics: Mr. Choo Chee Kong, Chairman and Director; and Dr. Tan Wee Kiat, PhD, Chief Operating Officer. Established in 2018, CytoMed is a biotechnology firm that originated from the Agency for Science, Technology and Research (A*STAR), Singapore's premier public sector research and development agency. The goal of CytoMed is to develop efficient and cost-effective cellular immunotherapy solutions for solid tumors and hematologic ...

Xtalks Speaks with Astellas Pharma's VP & Head of BioPharma Development Marci English About Menopause Drug Approval

June 28, 2023 09:00 - 19 minutes - 13.5 MB

This episode features an interview with Marci English, Vice President and Head of BioPharma Development at Astellas Pharma, about the recent FDA approval of the company’s drug Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause.  Hormone replacement therapy (HRT) has been the conventional treatment for menopause-associated vasomotor symptoms, otherwise known as hot flashes and night sweats; however, not all women can receive hormone th...

Wireless Charging for Medical Devices: Interview with Resonant Link’s CEO and Co-Founder Dr. Grayson Zulauf

June 21, 2023 09:00 - 26 minutes - 18.3 MB

In this episode, Vera interviews Dr. Grayson Zulauf, CEO and Co-Founder of Resonant Link, about the state of wireless charging for medical device implants today. Dr. Zulauf shares why improvements are needed for faster wireless charging.   Dr. Zulauf also shared insights into Resonant Link’s latest and the world’s fastest charger for titanium can-based medical device implants. He discussed the impact of this charger on patient care and quality of life. In addition, Vera and Dr. Zulauf discu...

In conversation with FNIH’s Dr. Courtney Silverthorn, Director of the AMP Bespoke Gene Therapy Consortium, About New Rare Disease Trial Portfolio

June 14, 2023 09:00 - 24 minutes - 17.1 MB

This episode features an interview with Dr. Courtney Silverthorn who is an Associate Vice President at the Foundation for the National Institutes of Health (FNIH) and the Director of the Accelerating Medicines Partnership (AMP) program including the Bespoke Gene Therapy Consortium.  The FNIH recently announced that the AMP Bespoke Gene Therapy Consortium has selected eight rare diseases for its clinical trial portfolio. Xtalks spoke with Dr. Silverthorm about the consortium’s new rare disea...

AI and ChatGPT for Medical Record Management: Interview with Carm Huntress, CEO and Founder of Credo Health

June 07, 2023 09:00 - 38 minutes - 26.7 MB

In this episode, Vera interviews Carm Huntress, CEO and Founder of Credo Health, about the challenges that the US healthcare industry is facing today with medical record management. Carm discusses why medical records should be digitized and the improvements needed for the retrieval and analysis of digital medical records. Vera and Carm also discussed how Credo Health’s new AI platform for medical records, PreDX, works and how it makes the tasks of healthcare providers easier. Carm also shar...

First Topical Gene Therapy + Bausch + Lomb's First Prescription Med for Dry Eye

May 31, 2023 22:00 - 26 minutes - 18.1 MB

In this episode, Ayesha talked about the FDA approval of the first topical gene therapy for the treatment of a rare skin condition. Krystal Biotech’s Vyjuvek is a topical gene therapy that has been approved for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB). It’s the first treatment for the rare disease. Hear more about DEB and Vyjuvek in this episode. Ayesha and the team also discussed the FDA approval of Bausch + L...

Veozah the New Drug for Menopausal Hot Flashes + SkinVive the New Dermal Filler

May 25, 2023 09:00 - 42 minutes - 29.2 MB

In this episode, Vera talked about the US Food and Drug Administration’s (FDA) approval of Veozah (fezolinetant), the new type of drug for menopausal hot flashes and night sweats. It is estimated that around 60 to 80 percent of women experience vasomotor symptoms (hot flashes, night sweats, etc.) during or after the menopausal transition. Importantly, vasomotor symptoms can have a substantial impact on daily activities and overall quality of life. The team discussed Veozah and the benefits o...

Interview with Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis

May 17, 2023 09:00 - 26 minutes - 18.5 MB

In this episode, Sarah interviews Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis, about the challenges of bring biosimilars to market. Dr. Woollett clears up some common misconceptions about achieving interchangeable status and addresses the issues with differences in global regulatory standards for biologics medicines.  Sarah and Dr. Woollett also discuss Samsung Bioepis’ first US Biosimilar Market Report (linked below) and some of its key findings on b...

World's First RSV Vaccine + First Novel Treatment for ALS

May 10, 2023 12:00 - 23 minutes - 16 MB

In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. RSV is a respiratory virus that causes mild to moderate cold and flu-like symptoms, but it can cause complications like lower respiratory tract disease (LRTD) and pneumonia in older adults and young children. Read more about the vaccine, including clinical trial results on its efficacy and safety.  Ayesha and ...

Axonics’ Non-Drug Incontinence Therapy + How AI Can Be Used to Study the Side Effects of Drugs

May 03, 2023 09:00 - 38 minutes - 26.4 MB

In this episode, Vera talked about how a couple of direct-to-consumer TV commercials have helped a medical device company, Axonics, establish its reputation in the non-drug incontinence therapy space. Around 87 million adults in the US and Europe have overactive bladder and it is estimated that an additional 40 million adults have fecal incontinence. Axonics offers innovative sacral neuromodulation (SNM) systems that are approved by the US Food and Drug Administration (FDA) for the treatment...

Interview with Cody Simmons, CEO of DermaSensor, Maker of a Handheld Skin Cancer Evaluation Tool

April 26, 2023 09:00 - 35 minutes - 24.3 MB

This episode features an interview with Cody Simmons, CEO of DermaSensor, a health technology company that aims to launch the world’s first point-and-click skin cancer detection tool for primary care providers. The skin cancer evaluation tool, also called DermaSensor*, is a point-and-click device that can provide health care practitioners with a skin evaluation in seconds.  As a bioengineer and entrepreneur, Cody has spent all of his career bringing new health technologies to physicians ...

EPA Proposes Stricter Ethylene Oxide Limits + Johnson and Johnson Offers $8.9 Billion Settlement

April 19, 2023 09:00 - 35 minutes - 24.7 MB

In this episode, Ayesha talked about new rules that the US Environmental Protection Agency (EPA is proposing for curbing ethylene oxide emissions from sterilization facilities. The agency says the new guidelines would help reduce emissions by 80 percent, which is particularly important for communities that live near sterilization plants and workers who work at them. Ethylene oxide is a known carcinogenic, with long-term exposure to the odorless, colorless gas being associated with cancers in...

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